Health Condition 1: null- Primary osteoarthritis of the knee, either unilateral or bilateral
Conditions
Interventions
Intervention1: Oxaceprol: Oxaceprol is an anti-inflammatory drug used in the treatment of osteoarthritis. It is derived from L-proline, a DNA-encoded amino acid. The active effect of Oxaceprol is to i
Sponsors
Institute of Postgraduate Medical Education Research
Eligibility
Inclusion criteria
Inclusion criteria: Clinically diagnosed cases of primary symptomatic OA affecting at least one knee joint (in case of bilateral knee involvement, the more symptomatic knee will be scored as the â??signal kneeâ??) fulfilling the following: • Age: Above 50 years • Sex: Either sex will be included • Knee joint pain present for at least one month in the preceding three months with at least one of the following: morning stiffness less than 30 min OR knee crepitus • Knee pain on movement of intensity at least 35 mm on a 100 mm VAS (Visual Analogue Score) scale.
Exclusion criteria
Exclusion criteria: • Secondary OA, such as due to injury, inflammatory condition, metabolic or rheumatic disease, osteonecrosis, Pagetâ??s disease, hemophilia etc. • Non-OA causes of knee pain in the signal knee (e.g. bursitis, fibromyalgia, osteonecrosis etc) • Prior intra-articular injection of hyaluronic acid / steroid / joint lavage in the study knee any time in the past three months. • Knee injury or diagnostic arthroscopy of signal knee within 6 months preceding enrollment or knee surgery (including arthroscopic surgery requiring an incision of the internal joint components) in the study knee, at anytime. • Severe and advanced OA disease, defined as joint space width 2 mm or deformed joint, or disease necessitating knee surgery in the current year. • Serious concomitant disease. • Subject unlikely to provide informed consent, follow the study protocol or any other criteria, which in the opinion of the investigator, is not conducive to enrollment of a particular subject into the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of oxaceprol in symptomatic primary osteoarthritis of the kneeTimepoint: Screening visit, baseline visit, follow up visit at 4th, 8th and 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile of OxaceprolTimepoint: Screening visit, baseline visit, follow up visit at 4th, 8th and 12th week | — |
Countries
India
Contacts
Public ContactKaushik Mukhopadhyay
Institute of Postgraduate Medical Education & Research
Outcome results
None listed